Passive Mobilisation of Region of Shoulder Joints for Hem... | NCT02904148

Studies
Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

NCT02904148

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Withdrawn

Last Update Posted

Nov 26, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hemiplegia

Interventions

Shoulder mobilisation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2019

Last Update Posted Date

Nov 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.

Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.

Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shoulder mobilisation	Experimental	The shoulder mobilisation is performed daily by a physiotherapist for 45 days.	Procedure: Shoulder mobilisation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shoulder mobilisation	Procedure	early shoulder mobilisation	Shoulder mobilisation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain evaluation with visual analogic scale	Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45	Change of pain evaluation between Day 0 and Day 45

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
Having made a cerebrovascular accident between 30 and 3 days before inclusion
with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
able to understand the question: "Do you have arm pain?"

Exclusion Criteria:

with visual analogue scale score lower than 20 mm at the inclusion
with aphasia of comprehension
with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
opposing to any mobilization
with shoulder pathology previously known
history of cerebrovascular accident prior 30 days before inclusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andre Muller, MD	CHU de La Réunion	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006429	Hemiplegia

Ancestor Terms

ID	Term
D010243	Paralysis
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided